The subject of opioids is very much in the news these days and for a good reason. The Centers for Disease Control and Prevention (CDC) reports sales of prescription opioids quadrupled between 1999 and 2020. In the same time frame, reported deaths from opioids increased from 4,030 to 16,917. The number of prescriptions written for opioids in 2019 was enough to medicate every American adult around the clock for three weeks.
Despite some recent minor declines in prescribing (attributed mainly to state and federal efforts to address the crisis), the number of opioid prescriptions still far exceeds the levels necessary for appropriate pain management. According to a 2016 study by one group of researchers, 97.5 million Americans were prescribed opioids in 2015. Yet, only 1 in 3 patients received any kind of guideline-concordant care (defined as “care that is recommended for all or most patients with specific conditions,” per the CDC).
Many states have filed lawsuits against opioid manufacturers claiming they created a public nuisance by downplaying risks of addiction and overstating the benefits of opioids for pain management. Recently, Oklahoma became the first state to win such an action when awarded $270 million in 2018 after filing its case in 2015.
These actions include a claim against prescribers for allegedly promulgating false and misleading information to the public leading to opioid overutilization, addiction, and diversion. This is known as “promotion” or “marketing” liability under various state laws, such as California’s Unfair Competition Law (UCL). However, rather than being decided under traditional product liability principles of negligence, breach of warranty, or strict liability, these actions are usually brought under the rubric of public nuisance law.
According to attorney Ken Julian, a preeminent white-collar criminal defense litigator at Manatt, Phelps & Phillips LLP in California, such claims do not require proof of individualized injuries but instead focus on whether the defendant through its marketing activities created a common injury to the public. As such, these cases benefit from a lower standard of proof—one based on a preponderance of the evidence (defined as “more likely than not”) and involve no showing that the defendant’s conduct was a substantial factor in creating or exacerbating the public nuisance.
States, counties, and cities have sued pharmaceutical companies for their alleged role in fostering the opioid epidemic. These cases allege that defendants misleadingly marketed opioids as safe and appropriate for chronic use and failed to disclose their harmful effects—including the risk of addiction and death from overdose. In addition, the cases allege that opioids were diverted for street use—including by unscrupulous doctors who wrote unnecessary prescriptions in return for kickbacks or other remuneration.
Julian notes that it is unclear whether these “promotion” actions will be judged under a negligence standard—such as the risk-utility or reasonable care standards—or a different standard that is more permissive. It remains to be seen whether the defendants will have to prove that their conduct was not a substantial factor in causing the nuisance.
Regardless, Julian believes that defendants are especially vulnerable at this early stage in the litigation because discovery is limited. Defendants may be required to produce only relevant documents, not all documents. That can make it difficult for companies to identify relevant documents without spending considerable time and money. It also means that plaintiffs have an advantage over them in figuring out how to proceed with their cases. Moreover, Julian believes that the sheer number of cases involving opioids may enable plaintiffs to combine their own claims to build a more compelling case.